changes in the hiv lab testing algorithm...some ways you can use office hour time discuss options of...

Changes in the HIV Lab Testing

Algorithm

Dr. Severin Gose

May 7, 2015

www.getSFcba.org

@getSFcba #SFLabTalk

Welcome!

Gary Najarian, M.S.W.

Manager, Capacity Building Initiatives

SFDPH, Center for Learning and Innovation

Contact Gary: 25 Van Ness Ave, Suite 500 San Francisco, CA 94102

T: (415) 437-6226 E: gary.najarian@sfdph.org W: www.getSFcba.org

Poll Question: What type of

organization do you work for?

Housekeeping

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What is Capacity Building Assistance

(CBA)?

CBA attempts to provide

information, training, and

technical assistance to the HIV

prevention workforce in order

to increase the adoption and

implementation of high impact

prevention strategies

HIV testing

Community-based testing – Thomas Knoble

Testing in clinical settings – Oliver Bacon, Stephanie

Cohen

Home testing- Hyman Scott, Oliver Bacon

Novel HIV testing technologies – Severin Gose

Linkage/partner services- Charles Fann

Internet Partner Services– Frank Strona, Charles Fann

Perinatal HIV and testing – Shannon Weber, Deb Cohan

Billing- Denise Smith, Athina Kinsley

Prevention for High Risk Negative

Persons

PrEP/PEP- Oliver Bacon, Stephanie Cohen, Jonathan

Fuchs, Albert Liu, Shannon Weber, Deb Cohan, Judy

Auerbach

Personalized Cognitive Counseling- Tim Matheson/Ed

Wolf

Policy/Planning

Use of data to support HIV continuum efforts- Data

to Care: Susan Scheer, Charles Fann, Erin Antunez, Darpun

Sachdev

Support of National HIV Behavioral Surveillance –

Henry Raymond Fisher

Social media to support outreach– Frank Strona,

Megan Canon (SFAF), Sapna Mysoor (AP&I WC)

Working with cross-sector partners – Eileen Loughran

Harm Reduction Strategies with IDU – Eileen

Loughran

Jurisdictional Planning – Dara Geckeler, Eileen Loughran

Ready to find out more?

Visit: www.getSFcba.org Email: get.SFcba@sfdph.org

Call: 415.437.6226

Changes in HIV Lab Testing Algorithm

Dr. Severin Gose

Director, SFDPH Lab

Thomas Knoble

Capacity Building Program Coordinator,

Community Health Equity & Promotion Branch,

SFDPH

Q&A Session Will Also Feature

Past – Brief overview of previous HIV

diagnostics

Future – New HIV diagnostics and the

updated algorithm

Case Study – San Francisco’s HIV testing

program

Webinar Overview

Disclaimer

Mention of any products, tools or services is for

explanatory purposes only and does not imply

their endorsement.

PAST – BRIEF OVERVIEW OF HIV

DIAGNOSTICS

2nd/3rd generation HIV diagnostics

Western Blot

Platform – Lab based

Method – Enzyme Immunoassay (EIA)

Detection – IgG only

Window period – >30 days

2nd Generation HIV Immunoassays

Platform – Lab based or rapid

Method – Enzyme Immunoassay (EIA)

Detection – IgG, IgM

Window period ~ 21 days

3rd Generation HIV Immunoassays

Platform – Lab based

Method – Colorimetric Immunoblot

Detection – IgG

Window period ~ 35 days

HIV Western Blot

FUTURE – NEW HIV DIAGNOSTICS

AND THE UPDATED ALGORITHM 4th generation HIV diagnostics

HIV-1/2 differentiation assays

HIV viral load assays

Platform – Lab-based or rapid

Method – Chemiluminscent

Microparticle Immunoassay (CMIA)

Detection - IgG, IgM, p24 (HIV antigen)

Window period ~ 14 days

4th Generation HIV Immunoassays

Platform – Lab-based (Multi-Spot)

Method – Microparticle Enzyme-Linked

Colorimetric Immunoassay

Detection – HIV-1 gp41 (antigen), HIV-2 gp36

(antigen)

Window period ~ 28 days

HIV-1/2 Differentiation Assays

Platform – Lab-based

Method – Real-time Reverse Transcription-

Polymerase Chain Reaction (RT-PCR)

Detection – HIV-1 RNA

HIV-1 Viral Load Assays

Pooling – similar to protocols used for blood

bank testing

10 serum specimens – mixed and tested

together, tested individualls if pool is positive

Cost-effectiveness – viral load testing is very

expensive, positive are very rare

HIV-1 Viral Load Assays

Thomas Knoble: Rolling out Determine™ 4th

Gen HIV Rapid Test in the Community

August 13 @ 11:00 am - 12:30 pm

Rapid (point of care) HIV Assays

Regulates all human diagnostic testing in the U.S.

Waived

–Rapid HIV tests

Moderate complexity

–MultiSpot, Architect 4th Gen.

High complexity

–Viral Load – not approved for diagnostic use, pooled

testing validated at SF PHL.

Clinical Laboratory Improvement

Amendments

Why make the change?

–Better tests

MultiSpot is more sensitive and easier than Western Blot

–Faster results

MultiSpot is faster than Western Blot

–Lower cost

Multispot is cheaper than Western Blot

–More information

MultiSpot differentiates between HIV-1 and HIV-2

–PSA: these statements all have caveats

Updated HIV Algorithm

CASE STUDY –

SAN FRANCISCO’S HIV TESTING

PROGRAM

High incidence of acute HIV cases

Intensive public health outreach and

surveillance

High-complexity laboratory resources available

These reasons make pooled-viral load

screening a viable option

What makes SF unique?

Rapid test positive, indeterminate or no

rapid test done

3rd/4th Gen. HIV Rapid Test (Stat-Pak)

4th Gen. HIV Immunoassay (Architect)

HIV-1/2 Differentiation Immunoassay (Multi-Spot)

Individual HIV Viral Load (RealTime HIV-1)

If Positive, Confirmed HIV Positive

If Negative, False Positive Immunoassay

Likely

3rd/4th Gen. HIV Rapid Test (Stat-Pak)

Pooled HIV Viral Load (RealTime HIV-1)

Individual HIV Viral Load (RealTime HIV-

1)

Rapid test negative

If Negative, Confirmed HIV

Negative

If Positive, Acute HIV Infection

Likely

Orthogonal rapid tests

–Two rapid tests using different methodologies

Rapid test expansion

–Many new rapid tests coming on market, many CE certified.

Rapid test vs. lab-based test barrier falling

CDC guidance still in draft format (2012)

Viral load screening is the future

POC testing is the future

Additional complexities to consider…

Thank you!

Please sign up for office hours!

1-on-1 Q&A on 4th Generation Lab

Testing

May 28 @ 10:00 am - 1:00 pm

Some ways you can use office hour time

Discuss options of increasing detection of early HIV cases

Talk with Severin about lab testing regulations and how

they affect implementation

Look at options for making acute screening cost effective

Get insider knowledge on what labs care about and how to

talk to your lab—a lab primer for non-lab rats!